10-20-2017 09:56 AM
What is the required ACPH in an ante room? USP <797> reads :
An ISO Class 7 (see Table 1) buffer area and ante-area supplied with HEPA-filtered air shall receive an ACPH of not less than 30
Does this mean an ISO 7 buffer and ISO 7 or 8 ante? So if I have an ISO class 8 ante room, should my room have a minimum of 30 ACPH?
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10-20-2017 12:31 PM
Unfortunately, USP 797 failed to specify the ACPH in the ISO Class 8 anteroom. The FDA Aseptic Processing Guidance stipulates a minimum of 20 ACPH. Remember you have an excellent set of references from the CriticalPoint Sterile Compounding Boot Camp. Our team is recommending 60 ACPH for an ISO Class 7 anteroom to ensure that a "state of control" can be maintained. If you can get 30 ACPH for an ISO Class 8 anteroom that would be great.